MFDS Holds Celltrion COVID-19 Antibody Treatment Verification Advisory Panel Meeting... Results to Be Announced on the 18th

[Asia Economy Reporter Dongwoo Lee] The Ministry of Food and Drug Safety announced on the 17th that it will verify Celltrion's novel coronavirus disease (COVID-19) antibody treatment 'Rekkironaju' (active ingredient Regdanvimab, code name CT-P59).

On the same day, the Ministry held a meeting of the 'COVID-19 Therapeutics and Vaccines Safety and Efficacy Verification Advisory Panel' to review the clinical trial results of Rekkironaju. The results will be disclosed on the 18th.

The advisory panel meeting will discuss whether Celltrion's clinical trial results can be recognized as evidence of Rekkironaju's therapeutic effects.

Prior to this, Celltrion explained that administering Rekkironaju to patients with mild to moderate COVID-19 reduced the recovery period by more than 3 days and decreased the incidence of severe cases by 54%.

The Ministry of Food and Drug Safety conducts approval reviews for COVID-19 vaccines and therapeutics through a 'triple' expert verification panel. The advisory process proceeds in the order of the verification advisory panel, the Central Pharmaceutical Review Committee, and the final inspection committee.

The verification advisory panel is the first step, gathering expert opinions on clinical, non-clinical, and quality fields. Thirty experts, mainly from infectious diseases, participate in the verification advisory panel.